The Amplatzer™ Family of Vascular Plugs

  AMPLATZER™ Vascular Plug II

Intended Use: The AMPLATZER™ Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature.

Contraindications: None known.

Warnings: The safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus or paravalvular leak closures) and neurological uses have not been established.

Precautions:

• This device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
• Use on or before the last day of the expiration month that is printed on the product packaging label.
• Patients with nickel allergy can experience an allergic reaction to this device.
• Do not use this device if the sterile package is open or damaged.
• This device should be used only by physicians who are trained in standard endovascular techniques. The physician should determine which patients are candidates for procedures that use this device.
• The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.
• Store in a dry place.
   

MRI Safety Information:

A patient with the Amplatzer™ Vascular Plug II may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient.
Device Name	Amplatzer™ Vascular Plug II
Static Magnetic Field Strength (B0)	1.5 T or 3.0 T
Maximum Field Spatial Gradient	19T/m (1900 gauss/cm)
RF Excitation	Circularly Polarized (CP)
RF Transmit Coil Type	Body Coil
Operating Mode	Normal Operating Mode
Maximum Whole Body SAR	2.0W/kg (Normal Operating Mode)
Maximum Head SAR	N/A
Scan Duration	2.0W/kg whole-body-averaged SAR for 15 minutes of continuous scanning
MR Image Artifact	The presence of this implant may produce an image artifact.

Potential Adverse Events: Potential complications include, but are not limited to: death, migration of the device, stroke, or vessel perforation.

State of California (USA) Only:
WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.